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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211172

EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: INOTERSEN SODIUM
Proprietary Name: TEGSEDI
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211172
Product Number: 001
Approval Date: Oct 5, 2018
Applicant Holder Full Name: AKCEA THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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